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US Health Care System

FDA advisory panels

Project: US Health Care System
Open-Content project managed by kuhan, mtuck

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An expert panel convened by the National Science Academy’s Institute of Medicine issues a report recommending a number of changes to how the FDA regulates the drug industry. The proposed changes are unanimously endorsed by the panel, comprised of 15 experts from academic and professional organizations. Some of the recommendations include:
bullet The FDA should implement a moratorium on direct consumer advertising of recently approved classes of drugs until enough aggregate data is available to confirm the drugs’ safety. Packaging for such medications should have a special symbol imprinted on them alerting consumers to the higher risk associated with new medications.
bullet The FDA should be required to reevaluate the safety and effectiveness of drugs at least once every five years after the drug has been approved. The agency’s current system for monitoring drug safety post-approval is far less effective than pre-approval testing. The report notes that there is a history of fierce disagreements between the FDA’s Office of Drug Safety and the agency’s Office of New Drugs.
bullet The FDA should be given new powers to impose fines, injunctions, and withdrawals when drug companies fail to complete the required safety studies.
bullet The agency should be given the authority to impose a wider range of restrictions on drugs it considers potentially unsafe.
bullet The government should require drug companies to register all clinical trials they sponsor in a government-run database so patients and physicians can review all studies. Currently, only those studies published in medical journals are accessible to the public, and these tend to be the studies that produce the most favorable results for the drug being tested.
bullet Expert advisory panels should not be loaded with industry-connected scientists. Most of the members making up these panels should be free of industry ties. “FDA’s credibility is its most crucial asset, and recent concerns about the independence of advisory committee members… have cast a shadow on the trustworthiness of the scientific advice received by the agency,” the report says. [Institute of Medicine, 9/22/2006; Washington Post, 9/23/2006; New York Times, 9/23/2006]

Entity Tags: US Food and Drug Administration, Institute of Medicine

Category Tags: Clinical drug studies, FDA advisory panels, Studies-Academic

The Food and Drug Administration (FDA) announces that it will not permit pharmacies to sell the emergency contraception drug “Plan B” without a prescription. The drug is a “morning-after” birth-control drug that prevents fertilization and the implantation of the embryo. The agency explains to the manufacturer of the drug, Barr Pharmaceuticals, that the government is worried about the possibility that teenaged girls might not understand how to correctly use the drug without a doctor’s advice. The FDA’s decision is in direct contradiction of a federal advisory panel’s 23-4 decision to recommend approving the drug for over-the-counter sales, including to teenagers, without a doctor’s approval. The FDA’s staff recommended that the agency follow the panel’s recommendation. In 2007, author and reporter Charlie Savage will write, “Normally, agencies such as the FDA base their decisions on the information provided by their expert advisory panels—but, strangely, not this time.” A spokesman for the presidential campaign of John Kerry (D-MA) says: “By overruling a recommendation by an independent FDA review board, the White House is putting its own political interests ahead of sound medical policies that have broad support. This White House is more interested in appealing to its electoral base than it is in protecting women’s health.” James Trussell, director of the office of population research at Princeton University and a member of the advisory board, says, “The White House has now taken over the FDA.” Numerous women’s groups accuse the FDA’s political appointees of overruling the experts in order to please social conservatives who believe that the “Plan B” drug encourages promiscuity and is a form of abortion. In the following months, a lawsuit will be filed to have the FDA’s decision overturned (see January 21, 2005 and After). [New York Times, 3/7/2004; Savage, 2007, pp. 300-301]

Entity Tags: Charlie Savage, Barr Pharmaceuticals, Bush administration (43), James Trussell, John Kerry, Food and Drug Administration

Timeline Tags: Civil Liberties

Category Tags: FDA advisory panels

The Center for Reproductive Rights (CRR) files a lawsuit against the Food and Drug Administration (FDA) asking that the courts reverse a recent FDA decision not to allow the so-called “morning-after” birth-control drug “Plan B” to be sold without a prescription (see May 6, 2004 and After). The CRR says the FDA’s decision was made based on politics and not science. CCR president Nancy Northrup will say that the FDA’s decision “broke its own rules, held Plan B to a higher standard than other over-the-counter drugs, and [as a result,] women have suffered the consequences.” Testimony and depositions gathered indicate that the FDA indeed placed politics over science in its decision. One scientist says that a deputy FDA commissioner told her that the over-the-counter (OTC) application for Plan B had to be rejected “to appease the administration’s constituents,” and that it could later be quietly approved for adults only (see March 4, 2008). Another scientist testifies that he learned before the 2004 decision was issued that then-FDA commissioner Mark McClellan—the brother of White House press secretary Scott McClellan—had already decided to disapprove the drug even before the FDA’s advisory panel had completed its analysis. However, McClellan will deny the accusation. [Center for Reproductive Rights, 11/14/2005; Savage, 2007, pp. 301-302]

Entity Tags: Mark McClellan, Center for Reproductive Rights, Nancy Northrup, Food and Drug Administration, Scott McClellan

Timeline Tags: Civil Liberties

Category Tags: FDA advisory panels

An expert panel convened by the US Food and Drug Administration unanimously agrees that Celebrex, Bextra, and Vioxx “significantly increase the risk of cardiovascular events” such as heart attacks. However the panel does not believe that the risk is so great that these drugs should be banned from the market. (Vioxx was withdrawn from the market voluntarily by its manufacturer in September (see September 30, 2004).) The sales of these drugs should be permitted to continue, but only under strict conditions, the panel says. It also recommends a prohibition on direct marketing to consumers, a patient’s guide for the drug, and a black box warning—the most severe possible—detailing the drug’s cardiovascular side effects. [CNN, 2/18/2005; Washington Times, 2/19/2005] After the vote, the New York Times reveals that 10 of the panel’s 32 members had at one time been paid-consultants to the makers of the drugs in question. In analyzing the votes, the Times discovers that neither Bextra nor Vioxx would have survived the vote if the scientists with connections to the company had not voted. For both Bextra and Vioxx, the industry-connected panelists voted 9 to 1 in favor, while the experts with no ties voted 14 to 8 and 17 to 15 to ban Bextra and Vioxx, respectively. The Times notes in its article that “these votes were deeply important” for the makers of those drugs. After the votes, the shares of Merck and Pfizer increase substantially. In e-mails to the Times, eight of the panelists, responding to questions from the newspaper, say their votes were not influenced by their ties to the companies. Two of the panelists do not respond. One of the panel members, Dr. John Farrar, who has received research support from Pfizer, says, “I think FDA would have a hard time finding people who are good at what they do who never spoke to a pharmaceutical company.” But another panel member, Dr. Curt Furberg, who has no ties, says he was “uncomfortable with the Pfizer-friendly undertone” at the meeting and he felt the industry ties might have contributed to that tone. Furberg adds that it has never been proven that Celebrex, Bextra, or Vioxx offer better pain relief than ibuprofen or more than a dozen other over-the-counter drugs. Daniel E. Troy, the FDA’s former chief counsel and a longtime advocate of drug-maker interests, plays down the importance of the ties, saying that any suggestion that experts’ votes were influenced by industry connections “buys into an overly conspiratorial view of the world.” [New York Times, 2/25/2005]

Entity Tags: Daniel E. Troy, John Farrar, Curt Furberg, US Food and Drug Administration

Category Tags: FDA advisory panels, Vioxx

In a 93-1 vote, the US Senate passes the Food and Drug Administration Improvement Act of 2007 (H.R.2273), which grants the FDA broad new authority to monitor the safety of drugs after they are approved. It was based in part on the recommendations of a 2001 report by the Institute of Medicine (see September 22, 2001). The institute had been asked by the FDA to examine drug safety after it was revealed that the FDA and drugmaker Merck had permitted the drug Vioxx to stay on the market despite numerous indications that it increased patients’ risk of a heart attack. But the bill that is passed is much weaker than the original version, and ignores some of the institute’s most critical recommendations. A USA Today investigation will find that industry-friendly changes made to the bill were instigated by senators “who raised millions of dollars in campaign donations from pharmaceutical interests.” For example, 49 senators successfully defeated an effort that would have allowed US consumers to import lower-cost drugs from Canada and other industrialized countries. The senators who opposed the provision “received about $5 million from industry executives and political action committees since 2001—nearly three quarters of the industry donations to current members of the Senate,” USA Today found. Another factor contributing to the amendment’s failure was that President Bush said he would veto the bill if it permitted the imports. Also excised from the bill was language that would have give the FDA the authority to ban advertising of high-risk drugs for two years. This was one of the Institute of Medicine’s key recommendations. Senator Pat Roberts (R-Kan) argued that the change would restrict free speech. Drug interests have given Roberts $18,000 so far this year, and $66,000 since 2001. Sen. Judd Gregg (R-NH) was responsible for a change that reduced the agency’s power to require post-market safety studies. He insisted on limiting this authority so that the FDA could only target drugs when there’s evidence of harm. Gregg has received $168,500 from drug industry interests since 2001. The bill’s main sponsors—senators Edward Kennedy, (D-Mass) and Mike Enzi (R-Wyo)—agreed to water down a proposal that would have required all clinical drug studies be made public after meeting with industry officials. The senators agreed to change the language so that only studies submitted to the FDA would be available. Enzi and Kennedy have received $174,000 and $78,000, respectively, from drug interests since 2001. Amendments aimed at reducing industry conflicts of interest on FDA expert advisory panels were also stripped from the bill. One of those amendments would have made it more difficult for scientists to advise the FDA on drug approval applications from a company the scientist had received money from. Another would have required that FDA panels consist of no more than one member with financial ties to the drug industry. The Senate also rejected an amendment to establish an independent FDA office to monitor the safety of drugs after they are released on the market. The office that currently has this authority is the same one that approves new drugs, an arrangement that lawmakers and at least one FDA scientist (see November 18, 2004) believe is a conflict of interest. [WebMD Medical News, 5/9/2007; US Congress, 5/10/2007; USA Today, 5/14/2007]

Entity Tags: George W. Bush, Edward M. (“Ted”) Kennedy, Judd Gregg, Mike Enzi, US Food and Drug Administration, Pat Roberts

Category Tags: Clinical drug studies, FDA advisory panels, Defense of corporate interests, Vioxx

A federal judge dismisses a lawsuit seeking to halt sales of the so-called “morning-after” birth control pill, the only such drug available in the US without a prescription. In 2006, the FDA reversed its 2004 decision not to allow the drug to be sold over the counter (see May 6, 2004 and After) to anyone 18 years of age or older. The suit was brought by the Association of American Physicians and Surgeons and a number of anti-abortion and social conservative groups. The US District Court in the District of Columbia finds that the plaintiffs failed “to identify a single individual who has been harmed by Plan B’s OTC [over-the-counter] availability.” The ruling is widely considered to be a victory for advocates of reproductive rights. “They still don’t have any evidence in terms of why they think it is harmful,” says Janet Crepps of the Center for Reproductive Rights (CRR). “This is the right decision for women.” A lawsuit filed by the CRR to force OTC sales of the drug to girls under 18 is still pending (see April 22, 2009). [Reuters, 3/4/2008]

Entity Tags: Association of American Physicians and Surgeons, Food and Drug Administration, Janet Crepps, Center for Reproductive Rights

Timeline Tags: Civil Liberties

Category Tags: FDA advisory panels

The Food and Drug Administration (FDA) announces that, in line with a judge’s recent ruling, it will approve the sale of the so-called “morning-after” emergency contraception pill to 17-year olds without a doctor’s prescription. A judge recently ruled in favor of the Center for Reproductive Rights (CRR) in a lawsuit against the FDA (see January 21, 2005 and After). Under the Bush administration, the FDA ruled that the pill, called “Plan B,” could not be sold without a prescription (see May 6, 2004 and After), a decision partially reversed in 2006. Conservative groups say the decision will make it more difficult for parents to supervise their teens; women’s rights groups say the decision strengthens the rights of women. District Judge Edward Korman ruled that the FDA’s political appointees placed politics over science in its decision to restrict over-the-counter (OTC) sales of the drug; he wrote that evidence showed White House officials pressured the FDA to reject the drug’s OTC sales. His ruling orders the FDA to allow OTC sales to 17-year olds, and to evaluate whether all age restrictions should be lifted. CRR’s Nancy Northrup says, “It’s a good indication that the agency will move expeditiously to ensure its policy on Plan B is based solely on science.” Wendy Wright of the conservative action group Concerned Women for America says, “Parents should be furious at the FDA’s complete disregard of parental rights and the safety of minors.” In 2008, a judge ruled that conservative groups had failed to prove that the drug posed a risk to anyone (see March 4, 2008). Former FDA official Susan Wood, who resigned in 2005 over the issue, says the battle over Plan B came to symbolize just how politicized the agency became under President Bush. “The FDA got caught up in a saga, it got caught up in a drama,” she says. “This issue served as a clear example of the agency being taken off track, and it highlighted the problems FDA was facing in many other areas.” [Associated Press, 4/22/2009; Washington Post, 4/23/2009] “We need to have a very strong and science-based agency, and this is one of those steps that will help strengthen it,” Wood says. [USA Today, 3/23/2009]

Entity Tags: George W. Bush, Bush administration (43), Center for Reproductive Rights, Food and Drug Administration, Susan Wood, Wendy Wright, Nancy Northrup, Edward Korman

Timeline Tags: Civil Liberties

Category Tags: FDA advisory panels

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